Test Overview
Clinical Utility
Aiding in the diagnosis of invasive fungal infections caused by various fungi, including Aspergillus species, Fusarium species, Candida species, and Pneumocystis jiroveccii, among others.
Method
Protease Zymogen-Based Colorimetric Assay
Method Description
The Fungitell assay measures levels of (1,3)-beta-D-glucan (BDG). The assay is based upon a modification of the limulus amebocyte lysate (LAL) pathway. The Fungitell reagent is modified to eliminate factor C and, thus, to only react to BDG, through the factor G-mediated side of the pathway. BDG activates factor G, a serine protease zymogen. The activated factor G converts the inactive proclotting enzyme to the active clotting enzyme, which in turn cleaves pNA from the chromogenic peptide substrate, Boc-Leu-Gly-Arg-pNA, creating a chromophore that absorbs at 405 nm. The Fungitell kinetic assay is based upon the determination of the rate of optical density (OD) increase produced by a sample. This rate is interpreted against a standard curve to produce estimates of BDG concentration in the sample.(Package insert: Assay for [(1,3]-Beta-D-Glucan in Serum. Associates of Cape Cod Inc; 02/2011)
Result Included
1,3-Beta-D-Glucan (Fungitell)
Specimen
Specimen Type
Serum
Containers
Collection Containers
Gold top (SST) Red top is not acceptable
Volume
Sample Volume
1 mL
Minimum Volume
0.5 mL
Collection & Handling
Collection Instructions
Collect specimen in gel-separator tube.
Handling Information
Avoid exposure of specimen to atmosphere to prevent environmental contamination of the sample. Centrifuge and send specimen in original collection tube. Do not aliquot or open tube.
Stability
| Refrigerated | Frozen |
|---|---|
| 14 days | 30 days |
Rejection Criteria
| Criteria | Specification |
|---|---|
| Hemolysis | Gross |
| Lipemia | Gross |
| Icterus | Gross |
| Specimen | Plain red top |
Performance & Interpretation
Turnaround Time
9 days
Results
-
Fungitell Quantitative Valuepg/mL<60
-
Fungitell Qualitative ResultNegative
Comment
This assay does not detect certain fungi, including Cryptococcus species, which produce very low levels of (1,3) Beta-D-Glucan (BDG) and the Zygomycetes (e.g., Absidia, Mucor and Rhizopus), which are not known to produce BDG. Additionally, the yeast phase of Blastomyces dermatitidis produces little BDG and may not be detected by this assay. This assay was performed using the FDA-cleared Fungitell Assay
(Associates of Cape Cod, East Falmouth, MA, USA), a kinetic ELISA based on modification of the Limulus Amebocyte Lysate pathway.
Referral Location
Out-of-Country
Interface & Setup
HL7 Interface Codes
| Order Code | Result Name | Result Codes | Units |
|---|---|---|---|
| SFUNG S | Fungitell Quantitative Value | 63356 | pg/mL |
| Fungitell Qualitative Result | 63357 |
Test Version
Last Updated
2024-02-20